Notice on the Release of Guidelines for the Preparation of Special Review Application Materials for Innovative Medical Devices (No. 127, 2018)

In order to implement the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices (Office Letter [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, and to further improve the preparation of application materials and technical review of innovative medical devices as stipulated in the Special Review Procedure for Innovative Medical Devices (Announcement No. 83 of the State Food and Drug Administration in 2018), the State Food and Drug Administration has organized the formulation of the Guidelines for the Preparation of Application Materials for Special Review of Innovative Medical Devices, which are hereby promulgated. The Guidelines for the Preparation of Application Materials for Special Review of Innovative Medical Devices (Announcement No. 166 of the State Food and Drug Administration in 2016) issued by the former State Food and Drug Administration are hereby repealed.

This is hereby announced.

Attachment: Guidelines for the Preparation of Application Materials for Special Review of Innovative Medical Devices

State Food and Drug Administration
December 12, 2018